Navigation Links
Johnson & Johnson Violated FDA Order to Halt Sales of Transvaginal Mesh
Date:6/27/2012

(PRWEB) June 27, 2012

In complete disregard of an order by the U.S. Food and Drug Administration (FDA) to stop marketing the Gynecare Prolift vaginal mesh implant, Johnson and Johnson (J&J) continued to sell the product for nine additional months. According to court records, in a letter dated August 24, 2007, the FDA advised J&J to halt the sales of the Gynecare Prolift until such time the agency determined whether the device was the “substantially equivalent” to other mesh products on the market. The letter clearly stated, “You may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval. “If you market the device without conforming to these requirements, you will be in violation of the Federal Food Drug and Cosmetic Act.” Despite this warning, J&J continued to sell the mesh product until the FDA cleared the device in May 2008 after months of negotiations with J&J.

J&J initially began selling the Prolift in 2005. It failed to apply for application and approval from the FDA because it unilaterally determined its product was substantially similar to the Gynemesh product already approved by the FDA, according to Matthew Johnson, J&J spokesman. The FDA disagreed and required a new application be submitted. The company’s failure to initially heed FDA orders could prove costly. Currently there are more than 1,400 lawsuits pending against J&J by women injure
'/>"/>

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Research shows efficacy of treatment model developed at Women & Infants
2. Soy-based S-equol supplement reduces hot flash frequency, muscle & joint pain in US women
3. Vendors in Nevada, Michigan, & Illinois to be Featured on the PartyPOP.com Online Network
4. Beef & Pork Wholesaling in the US Industry Market Research Report Now Available from IBISWorld
5. The Tennessee Car Accident Lawyers at Michael D. Ponce & Associates Alert Public of CDC Survey Revealing Majority of High School Seniors Admitting to Texting Behind Wheel
6. Alex Galindo, Attorney and Partner at Curd, Galindo & Smith, LLP, Court Wins Against the County of Riverside's Motion to Dismiss Medical Malpractice Case
7. Play & Park Structures Included in New Play for All Abilities Playground
8. Gum Disease, HPV May Play Role in Head & Neck Cancers
9. New Treatments Emerging from Immune and Inflammatory Disease R&D Pipelines
10. Version 2.0 of Award-Winning Proloquo2Go App for iPhone, iPad & iPod touch Speeds Up Communication, Adds New Voices and Customization Options
11. Ear, Nose & Throat Journal publishes research on breakthrough treatment for tonsil stones
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/1/2014)... (PRWEB) September 01, 2014 The Outlier ... with extended exclusive interview content from one of the ... Ingredients of Outliers: Women Game Changers . The title ... Outliers: Woman Game Changer Jenny McClendon . McClendon is ... and was formerly the star of WeTV show, Raising ...
(Date:9/1/2014)... Nevada (PRWEB) September 01, 2014 Beginning ... to over 3,000 medical professionals and 10,000 consumers for ... is a 5-day gathering of the nation’s top medical ... associated diseases or conditions. The week-long event contains more ... evidence-based scientific instruction available in the pain management field. ...
(Date:8/31/2014)... Washington, D.C.USA (PRWEB) August 31, 2014 ... the global community utilizing social media marketing tools ... and interactive programs. MMU will utilize all tools ... become learning partner for our multiple learning channels. ... new mobile app, and an authoring tool that ...
(Date:8/31/2014)... GoDaddy, IX Web Hosting and Bluehost ... Private Server) hosting, which is the method of ... each of which has the appearance and capabilities ... has recently compared many professional web hosting suppliers ... best VPS hosting suppliers in the global market. ...
(Date:8/31/2014)... In order to celebrate the coming of autumn, ... designs and launched a big promotion. Now, all the global ... the company’s new cars are made with great materials. FODAY ... customers. As a matter of fact, it is providing big ... are in need of cheap cars can visit its website ...
Breaking Medicine News(10 mins):Health News:Upcoming Outlier Series eBook about Jenny McClendon, PA-C, Former Start of Raising Sextuplets 2Health News:Upcoming Outlier Series eBook about Jenny McClendon, PA-C, Former Start of Raising Sextuplets 3Health News:Medical Marijuana Doctor Company Set to Present at Las Vegas Pain Week 2Health News:My Mobile University Announces Global Strategic Plan and Unveils New Android App to Enhance and Impact Lives World-Wide Through Education for All as Learning Platform 2Health News:My Mobile University Announces Global Strategic Plan and Unveils New Android App to Enhance and Impact Lives World-Wide Through Education for All as Learning Platform 3Health News:GoDaddy, IX Web Hosting and Bluehost Are Awarded As Hosting Experts by Top10BestSEOHosting.com 2
... Doheny HealthDay Reporter , WEDNESDAY, March 28 (HealthDay ... a woman,s risk of breast cancer by about 5 percent, ... drinking -- three or more drinks a day -- can ... Germany, France and Italy. "Alcohol consumption is ...
... Vanderbilt-Ingram Cancer Center researchers have identified a new population of ... of colorectal cancer. , This new stem cell population, reported ... be relatively quiescent (inactive) in contrast to the recent ... is marked by a protein, Lrig1, that may act as ...
... new UK alcohol strategy includes a plan to ensure that ... Government,s Alcohol Strategy, 23 March 2012, downloadable from http://www.homeoffice.gov.uk/publications/ ... much people drink. The big question is, what should GPs ... online by the scientific journal Addiction analysed the ...
... (HealthDay News) -- A drink or two per day may help ... a heart attack, a new study suggests. The research, which ... included more than 1,800 American men who survived a first heart ... 20 years. During that time, 468 of the men died. ...
... -- The common cold appears to increase the number ... more sensitive, which triggers coughing, wheezing and breathlessness, a ... vulnerable to this virus-induced coughing, said the researchers from ... as transient receptor potential (TRP) receptors. "TRP ...
... -- Researchers have identified genetic causes in nearly 1 in ... dilated cardiomyopathy. Carolyn Jones, MD, PhD, of Loyola University ... Journal of Cardiac Failure . First author is Neal ... genetic testing on 264 patients with dilated cardiomyopathy and found ...
Cached Medicine News:Health News:Even a Little Drinking May Raise Breast Cancer Risk: Study 2Health News:Even a Little Drinking May Raise Breast Cancer Risk: Study 3Health News:Newly identified stem cells may hold clues to colon cancer 2Health News:Moderate Drinking Might Help Men Live Longer After Heart Attack 2Health News:Research Shows How Colds Lead to Coughing, Wheezing 2Health News:Genetic causes found in nearly 1 in 5 patients with dilated cardiomyopathy heart failure 2
(Date:8/29/2014)... 2014 The Competitive Intelligence (CI) function is ... CI leaders who adjust will succeed, and those who ... Best Practices, LLC study CI leaders from 32 biopharmaceutical ... - Use secondary research whenever possible - it,s ... - Internal staff who are creative thinkers provide the ...
(Date:8/29/2014)... , Aug. 29, 2014  A Boston Scientific ... study on stent removability and preliminary long term ... published in the August issue of the peer-reviewed ... 1 is being conducted in 11 countries ... covered self-expanding metal stents (FCSEMS) after extended indwell ...
(Date:8/29/2014)... -- Thoratec Corporation (NASDAQ: THOR ), a ... save, support and restore failing hearts, said today it ... Healthcare Conference on Wednesday, September 10. ... will provide an update on the company, beginning at ... Time).   A webcast of the presentation ...
Breaking Medicine Technology:Using the Competitive Intelligence Function to Drive Better Business Decisions in the Pharmaceutical Sector 2Boston Scientific Study Published In Gastroenterology Reports Successful Management Of Benign Biliary Strictures With Fully Covered Metal Stents 2Boston Scientific Study Published In Gastroenterology Reports Successful Management Of Benign Biliary Strictures With Fully Covered Metal Stents 3Boston Scientific Study Published In Gastroenterology Reports Successful Management Of Benign Biliary Strictures With Fully Covered Metal Stents 4
... June 18 Naviscan,s Positron Emission Mammography (PEM) technology was the ... Annual Meeting in Salt Lake City .  The focus represents a ... in the fight against breast cancer.   , ... PEM scanners are high-resolution breast PET systems that can ...
... Allied Healthcare Products, Inc. (Nasdaq: AHPI ) today announced introduction ... patient safety over conventional absorbents in anesthesia procedures. , ... "Litholyme features a patented formulation ... absorbents, yet it has been developed in such a manner that ...
Cached Medicine Technology:Naviscan Positron Emission Mammography Technology Highlighted at the Society of Nuclear Medicine Annual Meeting 2Allied Healthcare Announces Litholyme(TM) -- New CO2 Absorbent Used in Anesthesia 2
Contains 50 mg/ml gentamicin sulfate in distilled water....
Gentamicin is an aminoglycosidic antibiotic that inhibits bacterial growth by inhibiting protein synthesis. Gentamicin is used for prevention and elimination of bacterial contaminants in cell culture...
LB Agar plates with 10mM Magnesium Sulfate....
LB Agar plates with 0.1mM EDTA....
Medicine Products: